SecurAcath Versus Statlock for PICC Securement (SecurAstaP)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Patients With Any Condition Who Need a PICC for IV Therapy

Treatments: Device: SecurAcath; Device: StatLock

Study type: Interventional

Funder types: Other

Identifiers

NCT02311127

S57358

Details and patient eligibility

About

Peripherally inserted central catheters (PICCs ) are used for the administration of intravenous fluids and for blood sampling. PICCs may remain in place for weeks to months and are safeguarded from migration or accidental dislodgement by securement devices. Different types of these devices are available. StatLock® (C.R. Bard) is a stabilization device with an adhesive anchor pad. The catheter wings of the PICC must be placed over the posts then the system is closed with "gull-wings" . StatLock® has to be changed weekly. Healthcare providers have to pay attention to prevent accidental catheter dislodgement during the renewal procedure. SecurAcath® (Interrad Medical) is a new securement device to the European market. The device uses a small subcutaneous anchor to secure the PICC. One of the advantages compared to adhesive stabilization devices, is a reduction in maintenance time by simplifying dressing changes and subsequently staff time. It is described that nurses report that care is left undone due to low staffing levels. Therefore, investigation of nursing time savings with the support of technology is imperative. SecurAcath® remains in place for life of the PICC and therefore has the potential to reduce the time for dressing change as there is no need for weekly device change. The objective of this study is to measure nursing time for dressing change and explore inserting and removal issues and patient experiences.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Polyurethane PICC insertion
• Dutch speaking patient, able to give informed consent
• Intravenous treatment is administered in the University Hospitals Leuven

Exclusion criteria

• patients with known allergy to nickel or ethylene oxide

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

SecurAcath

Experimental group

Description:

Subcutaneous securement

Treatment:

Device: SecurAcath

StatLock

Active Comparator group

Description:

Adhesive securement

Treatment:

Device: StatLock